21 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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InnoSEAL Hemostatic Pad
FDA 510(k)
FDA Unclassified
·Unknown
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304250789·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694040730·PrimaLIF LLIF 13mm x 22mm Lordotic Trial
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613045296·Vented Instrument Guards, Solid Green Radiopaqu...
Mui Scientific
FDA UDI
H & A Mui Enterprises Inc·10678467505351·CUSTOMIZED SINGLE-USE COLONIC 16CH CATHETER
MODIFICATION TO SCINTRON IV
FDA 510(k)
FDA Class 2
·Radiology
PLAYTEX EMBRACE PETITE BREAST PUMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·October 10, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
CONSTELLATION WITH LASER
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·June 17, 2011
G7 HI-WALL ARCOMXL LNR 36MM F
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code PBI·April 3, 2024
SHIRANUI EX
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·August 12, 2020
OHICHO3
FDA Adverse Event
Injury
·Product code LIT·July 19, 2019
SHIRANUI EX
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·August 14, 2020
SHIRANUI EX
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·September 30, 2020
SHIRANUI EX
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·May 28, 2020
OHICHO3
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·September 26, 2018
OHICHO3
FDA Adverse Event
Injury
·Product code LIT·September 17, 2019
BELLAFILL DERMAL FILLER
FDA Adverse Event
Injury
·SUNEVA MEDICAL, INC.·Product code LMH·June 18, 2021
Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use with the LCXO2 and AC31 PtO2 Monitors. It provides users with a secondary means to verify the monitor's PtO2 state-of-calibration (but does not provide calibration) when needed by providing a specific electrical signal to the monitor.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·June 11, 2014